Only 1 in 7 Chronic Pain Patients Use Opioids

By Pat Anson, PNN Editor

Have you tried physical therapy? What about yoga or Tai Chi? Did massage help you feel better?

Just about everyone in chronic pain has been asked that by family members, friends, doctors and sometimes even complete strangers.  The questions are innocent enough and usually well-meaning, but they often imply that a pain sufferer hasn’t looked beyond opioids for pain relief.

A new study shows that most people with chronic pain make extensive use of non-opioids and other “alternative” pain treatments – and that it’s relatively rare for a patient to only use opioids for pain relief.

The findings, published in JAMA Network Open, are based on answers to the 2019 National Health Survey by nearly 32,000 U.S. adults with chronic pain. The 2019 survey was the first to ask people about their use of 11 pain management techniques during the previous three months.

It turns out most people with chronic pain (54.7%) only used non-opioid pain management. And nearly a third (30.2%) used no pain therapy whatsoever. The rest either used opioids alone (4.4%) or a combination of opioids with one or more alternative treatments (10.7%).

That means only about 1 in every 7 adults with chronic pain even use opioids – a startling number when you consider the constant harping from anti-opioid activists and public health officials about how opioids are “overprescribed” in the U.S.   

“This study found that adults with chronic pain in the US use a variety of pain management techniques, including opioids,” wrote lead author Cornelius Groenewald, MB, a pediatric anesthesiologist and associate professor at the University of Washington School of Medicine. “Nonpharmacologic and nonopioid pharmacologic therapies are preferred treatments for chronic pain, and it is encouraging to note that most adults with chronic pain use a combination of various nonopioid modalities for treatment.”

Alternative Chronic Pain Therapies Used in 2019

• 18.8% Physical Therapy

• 17.6% Massage

• 15.6% Meditation or Relaxation Techniques

• 11.6% Spinal Manipulation or Chiropractic Care

• 8.5% Yoga or Tai Chi

• 5.1% Pain Self-Management Workshops

•  3.8% Psychological or CBT Therapy

• 1.8% Peer Support Group      

Nearly 40% of chronic pain sufferers reported using other therapies that were not listed in the survey. That may include treatments such as cannabis, kratom, medical devices, acupuncture or even ice packs. It would be good to include more of those options in future surveys.

Groenewald and his colleagues were disappointed that so few people used psychological techniques such as cognitive behavioral therapy (CBT), which was the only alternative pain therapy that they said was “underused.”   

The researchers found that complementary, psychological or psychotherapeutic therapies were more likely to be used by younger adults, females and people with more education. Adults using physical, occupational or rehabilitative therapies were more likely to be older, female, highly educated and have medical insurance.

Neuromodulation Device Effective for Most Migraine Sufferers

By Pat Anson, PNN Editor

A wearable neuromodulation device significantly reduced headache pain in nearly two-thirds of migraine sufferers, according to a new study. About one in four participants (22.6%) who used the device had no migraine pain after two hours.

The study findings, published in the journal Frontiers in Pain Research, are based on an analysis of over 23,000 remote electrical neuromodulation (REN) treatments with Nerivio, a device worn on the upper arm that uses mild electrical pulses to disrupt pain signals.

It’s important to note the study was designed and funded by Theranica Bio-Electronics, Nerivio’s manufacturer. Three of the five co-authors are Theranica employees.

“The current analysis of a very large group of patients, over a long period of time and multiple treatments, reinforces that REN provides a safe, efficacious and stable treatment option for acute treatment of migraine, both as a standalone and as an adjunct therapy. This is a very important component in the migraine therapy toolbox," lead author Jessica Ailani, MD, Director of the MedStar Georgetown Headache Center and Professor of Clinical Neurology, said in a press release.

Nerivio is controlled by a smartphone app that allows patients to set the intensity of their 45-minute treatments at the onset of a migraine. The app also has a migraine diary that allows patients and their doctors to track the effectiveness of REN.

It is from this app that study data was collected from 12,151 U.S. patients from 2019 to 2021. Most had been prescribed REN by headache specialists, indicating their migraines were difficult to treat with pain medication alone. During the study, about two-thirds of patients only used REN, with the remainder continuing to use over-the-counter or prescription medications.

"To the best of our knowledge, this study is the largest prospective real-world evidence analysis of a migraine device to date," said Alon Ironi, CEO of Theranica.

Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

Although migraine sufferers have many new treatments available, such as CBD oil and calcitonin gene-related peptide (CGRP) inhibitors, many find them too expensive or ineffective. Theranica hopes Nerivio can help fill the treatment gap, either as a standalone replacement for medication or as an adjunct.

"While some people with migraine get relief from prescribed or even over-the-counter medications, others do not respond to medications, or cannot tolerate their side effects. There are also people who cannot use medications due to contraindications or being at risk of drug-drug interactions or medication overuse headache,” Ailani said.

The FDA approved Nerivio as a treatment for acute migraine in adults in 2019. Last year the label was expanded to include children over the age of 12 with episodic or chronic migraine. Over 25,000 people in the U.S. have used the device, according to Theranica.

Nerivio is only available by prescription. When purchased wholesale, the listed price is $599 for a twelve-treatment unit, although buyers can save money by enrolling in a patient savings program, depending on their insurance coverage.  

Experimental Gene Therapy Could Cure Sickle Cell Disease

By Pat Anson, PNN Editor

Experimental gene therapy is helping sickle cell patients develop normal red blood cells and could potentially be a cure for the disease, according to research recently published in The New England Journal of Medicine.

In early-stage Phase 1 and 2 clinical trials at the University of Alabama at Birmingham, 25 patients treated with a gene therapy called LentiGlobin produced stable amounts of red blood cells containing hemoglobin after a single infusion. 

Sickle cell disease is a genetic disorder that causes red blood cells to form in a crescent or sickle shape, which creates painful blockages in blood vessels that can lead to anemia, infections, strokes and organ failure. About 100,000 Americans live with sickle cell disease, primarily people of African or Hispanic descent.

Unlike other gene therapies that edit or silence genes, LentiGlobin adds a modified gene that reprograms the diseased blood cells.  

“In this therapy, we do not change or edit the gene that causes sickle cell disease,” says Julie Kanter, MD, director of the UAB Adult Sickle Cell Clinic. “Instead, we use a viral vector to deliver a new gene that will make a healthy hemoglobin — a beta hemoglobin — into the stem cell. This is like coding new instructions into the cell.”

The new hemoglobin -- called HbAT87Q -- is slightly different from regular hemoglobin and is less likely to cause red blood cells to be misshaped.  The HbAT87Q can also be measured more accurately inside the cell, allowing doctors to know how much of the new hemoglobin a patient is making on their own.

Although the gene therapy looks promising, researchers say more advanced studies are needed to make sure LentiGlobin is safe and effective long-term. 

“In an earlier part of this study, we were not able to get enough of the new gene into each cell,” explained Kanter. This caused the blood cells to be stressed and for some patients to still have symptoms of sickle cell disease. Two patients in the initial group developed leukemia.  

“We need to see that we have fixed this problem, says Kanter. “We also need to make sure this procedure both reduces pain/stops all pain crisis and prevents organ damage from sickle cell. This will take time. We will have to watch people for the next two to 15 years and measure their organ function compared to those who did not get this therapy.”

A 2020 report by the National Academies of Sciences, Engineering, and Medicine called for major changes in the way sickle cell disease is treated in the U.S. Compared to other chronic illnesses, stem cell disease has received little attention from the healthcare community, resulting in a lag in the development of new treatments.

Many stem cell patients also feel stigmatized when they have a pain flare and go to an emergency room, because ER staff are often ignorant about the disease and believe patients are seeking drugs.

“People with sickle cell disease have endured unnecessary hardship for more than 100 years. They have fewer medications and therapies than many other diseases and have received much less attention and funding. We need new and better options for people with sickle cell disease,” said Kanter.

Bone marrow and stem cell transplants are currently the only cures for sickle cell disease, but it’s often difficult to find good donors. Fewer than one in five people with the disease have compatible donors.

Spending Time in Nature Can Reduce Chronic Pain

By Gabriella Kelly-Davies, PNN Columnist

A few months ago, I took part in a panel discussion with three other women who live with migraine or chronic headaches. One speaker, Australian journalist Sarah Allely, described how immersing herself in nature helped to relieve her debilitating headaches, anxiety and depression after a mild traumatic brain injury. It also drastically improved her focus and concentration.

Sarah’s brain injury occurred in 2015, when a passing car knocked her off her bicycle. Afterwards, a headache erupted in the base of her skull whenever she tried to read, write, watch television, or listen to music. She also struggled to concentrate and couldn’t work as a journalist for eight months.

Noisy environments such as bars, cafes and social gatherings that for years had energized Sarah, became unbearable. Despairing, she asked her medical team for advice. Her doctors admitted there wasn’t much they could do and suggested she learn to accept the situation. Sarah’s spirit sank as she contemplated a bleak future without all the things that had previously given her purpose and pleasure.

But that all changed when her friends invited her on a bush walk.

While trekking through the bush, Sarah’s headache lifted. So did her anxiety and depression. She wondered whether it was a fluke or if spending time in nature had reduced her symptoms.

During the following weeks, Sarah visited local bushland whenever possible. To her surprise, every time she did this, her headache, anxiety and depression eased. Intrigued, she wondered whether going to a local park or sitting in her garden would have a similar effect. She tried it. To her amazement, it worked!

A while later she stumbled across some magazine articles about research around the healing powers of nature. Curious about why her symptoms eased whenever she spent time in nature, Sarah decided to make an audio documentary. She wanted to understand the science behind her experience and the “optimum dose of nature” to relieve her physical and emotional pain.

During her research, Sarah came across several American scientists who were studying the science underpinning the healing effects of nature. Excited, she interviewed them, turning the conversations into six episodes of a podcast series she named Brain on Nature.

In the free podcast, Sarah shares her experiences discovering the healing powers of the natural world. Each episode follows her quest to discover why the natural environment changed her brain, helping her recover from a brain injury.

Seeking Connections With Nature

The scientists Sarah interviewed told her they were asking the same questions as her. Their studies found spending time in nature improved psychological and physical health, but they couldn’t pinpoint the precise reason for this response. Still, they were confident certain theories did help explain what was happening.

One of these theories is called biophilia, a belief that humans have an innate tendency to seek connections with nature. But for many of us living in bustling urban settings, constant traffic noise, bright lights, sirens, flashing billboards and yelling are the norm, and connecting with nature is a dream rather than a reality.

Instead of relaxing or exercising in a natural environment, we multitask, work on computers, talk on mobile phones, scroll through social media and send text messages. Living this way increases our stress levels, and for people with chronic pain, this can mean more pain.

But there is good news. Several studies show that when people turn off their electronic devices and sit in a quiet garden or stroll in a park, they feel refreshed and relaxed.

Pain specialists know that when a person living with chronic pain is calm, the volume of pain signals racing through their nervous systems is less than when they are anxious, angry or upset. So it makes sense that pain could reduce after spending time in a relaxing environment such as a garden or park.

Another possible explanation for Sarah’s experiences comes from Rachel and Stephen Kaplan’s Attention Restoration Theory. The Kaplans propose that exposure to nature is not only enjoyable but also relaxing and revitalizing. In Sarah’s case, whenever she spends time in the mountains on a weekend, she remains headache-free the following week. Her focus and concentration are also better. 

Fortunately, benefiting from the healing effects of nature is not about climbing Mount Everest or going on three-day treks in the forest. It can be a 10-minute walk in a local park or sitting in the garden smelling the flowers.

Once she understood the natural world was helping her injured brain to recover, Sarah felt compelled to share her learnings with others whose health might benefit from a dose of nature.  

“No one in the medical world suggested immersing myself in nature could reduce my symptoms,” she says. “But it works. I want others to know about it so they can try it for themselves.”

Hundreds of thousands of people around the world have listened to Brain on Nature and Sarah says their response is overwhelmingly positive.

“Two years after launching Brain on Nature, I’m still getting emails every week from people who say their life changed after listening to the podcast,” Sarah says. “I’m delighted it continues to have a positive impact and my search for answers has helped so many people.”

Sarah accepts some people might be skeptical about her belief in the natural world’s healing effects, especially if they have lived with chronic pain for several years and nothing has helped. She understands this response, but encourages anyone in pain to try a dose of nature for themselves to see if it eases their pain or improves their mood.

“When your pain is bad or you’re feeling grumpy, anxious or depressed, take yourself for a walk in the garden or a park,” Sarah suggests. “Put your phone on flight mode and see how you feel when you come back. Do you feel different? I challenge you to say spending time in nature doesn’t make any difference. So far I haven’t met anyone who can say that.”

While immersing ourselves in nature might not be a cure for chronic pain, it’s a powerful option in our pain management toolbox. Since learning about this approach, I now turn off my phone whenever we go for our morning stroll. Instead of feeling harassed by too many phone calls and text messages during our walk, I now feel relaxed and centered. And when I’m calm, I have less pain. I hope you do too.

Gabriella Kelly-Davies lives with chronic migraine.  She recently authored “Breaking Through the Pain Barrier,” a biography of Australian pain specialist Dr. Michael Cousins. Gabriella is President of Life Stories Australia Association and founder of Share your life story.

Exercise Reduces Pain by Increasing Beneficial Bacteria

By Pat Anson, PNN Editor

Regular exercise can benefit people in many different ways, helping us lose weight, reduce the risk of heart disease, and boosting overall health.  

But researchers at the University of Nottingham have found that exercise has an unexpected benefit for people with arthritis. Regular exercise increases levels of beneficial bacteria in their digestive tracts, which reduces pain and inflammation by increasing levels of endocannabinoids – cannabis-like substances naturally produced by the body.

The study, published in the journal Gut Microbes, is believed to be the first to find a potential link between endocannabinoids, exercise and gut microbes.

"Our study clearly shows that exercise increases the body's own cannabis-type substances. Which can have a positive impact on many conditions,” says lead author Amrita Vijay, a Research Fellow at Nottingham’s School of Medicine. "As interest in cannabidiol oil and other supplements increases, it is important to know that simple lifestyle interventions like exercise can modulate endocannabinoids."

Vijay and her colleagues enrolled 78 people in their study. Half of the participants did 15 minutes of muscle strengthening exercises every day for six weeks, and the rest did nothing. Blood and fecal samples were collected from both groups.

At the end of the study, participants who exercised not only had lower pain levels, they also had significantly more Bifidobacteria and Coprococcus 3 -- bacteria that produce anti-inflammatory substances and lower levels of cytokines, which regulate inflammation.

These gut bacteria were particularly adept at raising levels of short chain fatty acids (SCFAs), which increase levels of endocannabinoids. About a third of the anti-inflammatory effects of the gut microbes was due to their ability to raise endocannabinoid levels.

Importantly, the exercise group also had lower levels of Collinsella – a bacteria known to increase inflammation that is strongly associated with processed food and diets low in vegetables.    

“In this study we show that circulating levels of ECs (endocannabinoids) are consistently associated with higher levels of SCFAs, with higher microbiome diversity and with lower levels of the pro-inflammatory genus Collinsella. We also show statistically that the anti-inflammatory effects of SCFAs are up to one third mediated by the EC system,” researchers concluded.

Previous studies have also found an association between gut bacteria and painful conditions. A 2019 study at McGill University found that women with fibromyalgia had 19 different species of bacteria that were present in either greater or lesser quantities than a healthy control group.

Bacteria associated with irritable bowel syndrome, chronic fatigue syndrome and interstitial cystitis were also found to be abundant in the fibromyalgia patients, but not in the control group.    

Having a healthy diet can also affect pain levels for migraine, neuropathy and other types of chronic pain. A recent study funded by the National Institutes of Health found that migraine sufferers who ate more fatty fish and reduced their consumption of polyunsaturated vegetable oils — frequently found in processed foods — had fewer headaches.

FDA Approves First Virtual Reality Device for Chronic Low Back Pain

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has authorized the marketing of the first home-based virtual reality (VR) device for the treatment of chronic lower back pain in adults.

The EaseVRx headset uses guided VR programs to help patients relax, meditate and distract themselves from their pain, using the principles of cognitive behavioral therapy (CBT). The device is made by AppliedVR, a Los Angeles-based company that is developing therapeutic VR programs to help treat pain and other conditions.

"Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life," Christopher Loftus, MD, acting director of the FDA’s Office of Neurological and Physical Medicine Devices, said in a statement. “Today's authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain."

Chronic lower back pain is defined as moderate to severe pain in the lower back lasting longer than three months. It is one of the most common chronic pain conditions and a leading cause of disability.

The FDA’s marketing approval is based a clinical study of 179 participants with chronic lower back pain. Half were given an EaseVRx headset to watch immersive 3-D programs daily for 8 weeks. The other half also used the headset, but only watched routine nature scenes as a sham treatment.

APPLIEDVR IMAGE

At the end of treatment, 66% of those who watched VR programs reported at least a 30% reduction in pain, compared to 41% of participants in the sham control group.

Nearly half of those in the EaseVRx group reported at least a 50% reduction in lower back pain.

No serious adverse events were reported during the study. About 20% of participants reported discomfort with the headset and nearly 10% reported motion sickness and nausea.

EaseVRx was given a Breakthrough Device Designation by the FDA in 2020 for treating fibromyalgia and chronic lower back pain. The designation speeds up the development and review of new medical devices.

Marketing approval of EaseVRx – known as a "De Novo pre-market review" – creates a new regulatory classification for VR devices. It clears the way for similar devices with the same intended use to obtain marketing authorization – a significant development for the fledgling virtual reality industry.

"We worked tirelessly over the past few years to build an unmatched body of clinical evidence that demonstrates the power of VR for the treatment of pain, and couldn't be more thrilled to achieve this important milestone," said Josh Sackman, AppliedVR’s co-founder and president. "But, our mission does not stop with this one approval. We're committed to continuing research that validates our efficacy and cost-effectiveness for treating chronic pain and other indications."

EaseVRx will only be available by prescription. Its software programs immerse users in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery.  The content also incorporates biopsychosocial pain education, diaphragmatic breathing, mindfulness, and relaxation exercises.

AppliedVR headsets are already being used for pain management in over 200 hospitals and healthcare systems. A company spokesman told PNN that EaseVRx will be available on a limited basis through select providers toward the middle of 2022, with a full commercial launch expected in 2023. AppliedVR's is currently building a distribution network and working with insurers -- Medicare, Medicaid and commercial -- to establish reimbursement levels. No pricing plans have been announced for its VR headset or programs.

Experimental Injection Could Reverse Spinal Cord Injuries

By Pat Anson, PNN Editor

An experimental injection therapy that uses synthetic nanofibers to stimulate nerve cells could be used someday to reverse paralysis and repair damaged spinal cord tissues, according to a new study by researchers at Northwestern University.

In experiments on laboratory animals, the therapy successfully regenerated spinal cord nerves, reduced scar tissue and triggered the formation of new blood vessels. After a single injection, paralyzed mice regained the ability to walk within four weeks.

“Our research aims to find a therapy that can prevent individuals from becoming paralyzed after major trauma or disease,” said lead author Samuel Stupp, PhD, an expert in regenerative medicine and founding director of the Simpson Querrey Institute for BioNanotechnology (SQI) at Northwestern.

“For decades, this has remained a major challenge for scientists because our body’s central nervous system, which includes the brain and spinal cord, does not have any significant capacity to repair itself after injury or after the onset of a degenerative disease. We are going straight to the FDA to start the process of getting this new therapy approved for use in human patients, who currently have very few treatment options.”

Stupp and his colleagues used nanotechnology to develop synthetic nanofibers that mimic the natural environment around the spinal cord. Intensifying the motion of molecules within the nanofibers promotes the repair and regeneration of myelin, the insulating layer of axons that help nerve cells transmit electrical signals.

Researchers say the nanofibers biodegrade into nutrients for nerve cells within 12 weeks and completely disappear from the body without noticeable side effects. Their study, published in the journal Science, is the first in which researchers controlled the motion of molecules through changes in chemical structure to increase a therapy’s efficacy.

Nearly 300,000 people are currently living with a spinal cord injury in the United States. About 30% are hospitalized at least once a year after the initial injury and less than 3% of those with a severe injury ever recover basic physical functions. Life expectancy for patients with spinal cord injuries is significantly lower than healthy people and has not improved since the 1980s.

“Currently, there are no therapeutics that trigger spinal cord regeneration,” Stupp said in a news release. “I wanted to make a difference on the outcomes of spinal cord injury and to tackle this problem, given the tremendous impact it could have on the lives of patients.” 

The key behind Stupp’s breakthrough therapy is fine tuning the motion of molecules so that they can find and constantly engage with moving cellular receptors with bioactive signals. Injected as a liquid, the “dancing molecules” immediately form a gel in a complex network of nanofibers that mimic the extracellular matrix of the spinal cord.

“Receptors in neurons and other cells constantly move around,” Stupp said. “The key innovation in our research, which has never been done before, is to control the collective motion of more than 100,000 molecules within our nanofibers. By making the molecules move, ‘dance’ or even leap temporarily out of these structures, known as supramolecular polymers, they are able to connect more effectively with receptors.”

Stupp and his team found that fine-tuning the molecules’ motion within the nanofibers makes them more agile and results in greater therapeutic effect in paralyzed mice. They also confirmed that formulations of their therapy performed successfully in vitro tests with human cells, indicating increased bioactivity and cellular signaling.

Once connected to the nerve receptors, the dancing molecules trigger two cascading signals, both of which are critical to spinal cord repair. One signal induces myelin to rebuild around axons, which improves how nerve cells communicate with the brain. The second signal helps neurons survive after injury by promoting the regrowth of lost blood vessels that feed neurons and other cells for tissue repair. The therapy also reduces glial scarring, which acts as a physical barrier that prevents the spinal cord from healing. 

“The signals used in the study mimic the natural proteins that are needed to induce the desired biological responses. However, proteins have extremely short half-lives and are expensive to produce,” said first author Zaida Álvarez, a former research assistant in Stupp’s laboratory who is now a researcher scholar at SQI. “Our synthetic signals are short, modified peptides that — when bonded together by the thousands — will survive for weeks to deliver bioactivity. The end result is a therapy that is less expensive to produce and lasts much longer.”

While the new therapy could be used to treat paralysis after a major spinal cord injury, Stupp believes it could also be used to as a therapy for neurodegenerative diseases and strokes.

“The central nervous system tissues we have successfully regenerated in the injured spinal cord are similar to those in the brain affected by stroke and neurodegenerative diseases, such as ALS, Parkinson’s disease and Alzheimer’s disease,” Stupp said. “Beyond that, our fundamental discovery about controlling the motion of molecular assemblies to enhance cell signaling could be applied universally across biomedical targets.”

You can learn more about Stupp’s research in this podcast and by watching this video:

Recent research at Yale University and Sapporo Medical University in Japan found that injections of mesenchymal stem cells (MSCs) in patients paralyzed by spinal cord injuries led to significant improvement in their motor functions. In a small study, more than half of the paralyzed patients showed substantial improvements in function within weeks of being injected with autologous MSCs derived from their own bone marrow.

Guidelines Urge More Caution in Use of Invasive Neck Procedures

By Pat Anson, PNN Editor

Invasive procedures such as steroid injections, nerve blocks and radiofrequency ablation should be used more cautiously when treating chronic neck pain, according to new guidelines adopted by the American Academy of Pain Medicine and American Society of Regional Anesthesia and Pain Medicine.

The two medical societies formed a joint guidelines committee in 2020 to look into cervical spine joint procedures, which are increasingly used despite questions about their effectiveness and safety. The use of radiofrequency ablation -- heat from an electric current used to burn painful nerve endings — has increased by 112% in the U.S. over the past decade.

Spine pain in the neck or lower back is the leading cause of disability worldwide, with nearly half of adults likely to be affected at some point in their lives. The cervical facet joints, which allow the neck and back to tilt forwards, backwards and to rotate, are the primary source of pain in about 40% of patients with chronic neck pain and over half of those with neck pain after whiplash injury.

"It is precisely because neck pain and cervical spine procedures are so common, and there is so little high-quality evidence to guide care, that consensus guidelines are needed,” says lead author Steven Cohen, MD, a professor of anesthesiology at Johns Hopkins Hospital and co-chair of the guidelines committee.

The new guidelines, published online in the journal Regional Anesthesia & Pain Medicine, are based on over 400 publications and clinical studies of cervical spine procedures. Reviewers also looked at clinical signs and imaging used to select patients for particular procedures; the diagnostic and prognostic value of procedures; and several aspects of radiofrequency ablation (RFA), including how to reduce the risk of complications from the procedure and whether it should be repeated.

Because acute neck pain often resolves by itself, the guidelines recommend 6 weeks of conservative management, such as non-opioid painkillers and physical therapy, before opting for RFA or nerve blocks.

The reviewers found that RFA may be helpful for easing chronic neck pain, but only in patients whose pain corresponds to the joints being treated; those whose symptoms don’t emanate from a nerve root; and those who obtain meaningful pain relief from diagnostic nerve blocks, which are typically performed before RFA. 

Many insurance carriers require two nerve blocks, but the evidence indicates that doubling up will result in a significant number of unnecessary procedures and higher costs. Reviewers say the evidence for performing only a single block is much stronger for the neck than for the lower back.

The guidelines also recommend against stringent patient selection criteria, such as requiring nearly total pain relief from diagnostic blocks, because it might exclude patients who might benefit from radiofrequency ablation. None of the clinical studies that were reviewed support using pain relief thresholds above 50 percent.

Physicians should warn patients about the common side effects of RFA, such as tingling and burning sensations, numbness, dizziness, and loss of balance and coordination, which can last from a few days to a few weeks after the procedure. Patients also need to be told that RFA won’t cure them, and that pain relief typically lasts between 6 and 14 months. 

While most patients who have the procedure repeated will get pain relief, the benefits may wane over several years. RFA shouldn’t be repeated more than twice a year, the guidelines recommend.

Other key recommendations include:

• Use only soluble, short-acting steroids when injecting into the upper neck joints

• Use fluoroscopy imaging before spinal injections to avoid inadvertent needle placement

• Use smaller needles and electrodes than those used for the lower back

• Use nerve and muscle stimulation to improve effectiveness and reduce the risk of complications

• Take steps to minimize interference with implanted electrical devices such as pacemakers

“Clinical trials evaluating cervical facet blocks and RFA are characterized by widely disparate outcomes, and there is enormous variation in selecting patients and performing procedures. These multi-society guidelines have been developed to serve as a roadmap to improve outcomes, enhance safety, and minimize unnecessary tests and procedures,” the reviewers concluded.

Integrative and Comprehensive Pain Management Provide Only Small Benefits

By Pat Anson, PNN Editor

As concerns rose in recent years about opioid addiction and overdoses, it became trendy for healthcare providers to offer “comprehensive” or “integrative” pain management programs to patients – usually a combination of medication, physical and behavioral therapy, lifestyle changes and alternative treatments such as massage and acupuncture.

But a new study commissioned by the Agency for Healthcare Research and Quality (AHRQ) found that integrative and comprehensive pain management provide only small improvements in pain and function for people with chronic pain.   

Researchers at Oregon Health & Science University (OHSU) reviewed 57 “fair quality” clinical studies, most involving patients with moderate chronic pain caused by fibromyalgia, osteoarthritis and musculoskeletal conditions. Although the improvements in pain and function were small and the evidence limited, researchers concluded that integrative (IPMP) and comprehensive (CPMP) pain management programs worked about as well as individual treatments.

“Our review suggested that IPMPs and CPMPs may provide small to moderate improvements in function and small improvements in pain for patients with chronic pain compared with usual care and may be more effective than some medications alone. The average improvements in function and pain in our review were consistent with those reported for other therapies for pain, including opioids for chronic pain, nonpharmacologic treatments, and surgery,” researchers found.

One of the problems researchers encountered was the mish-mash of terms used to define integrative and comprehensive pain management – such as multimodal, multidisciplinary, interdisciplinary and biopsychosocial – the meaning of which often varies from provider to provider. Researchers said there was “no firm consensus on their definition or use,” which made it harder to evaluate their effectiveness. Only a few of the reviewed studies compared treatments head-to-head and many were of poor quality.

Although none of the trials specifically included Medicare patients, researchers concluded that IPMPs and CPMPs should be more widely used to address pain in the Medicare population.   

“To the extent that programs are tailored to patients’ needs, our findings are potentially applicable to the Medicare population. Programs that address a range of biopsychosocial aspects of pain, tailor components to patient need, and coordinate care may be of particular importance in this population,” they said. 

“Although use of selected individual treatments may serve some patients, a broader range of therapies that address the full scope of biopsychosocial concerns available in formal programs may benefit others. Research in the Medicare population and in patients with a broader range of pain conditions is needed as is research on the impact of program structures, coordination methods, and components on patient outcomes. Additional evidence from primary care-based programs is particularly needed.” 

One of the co-authors of the AHRQ study is Dr. Roger Chou, a primary care physician who heads the Pacific Northwest Evidence-based Practice Center at OHSU.  Chou, who co-authored the 2016 CDC opioid guideline, is a prolific researcher who has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid advocacy group.

PROP Vice President Gary Franklin, MD, “provided input” on the AHRQ study, as well as others.

In July, Chou declared a conflict of interest and recused himself from a meeting of the CDC’s Board of Scientific Counselors, which is evaluating a revision and possible expansion of the agency’s controversial guideline. Chou’s recusal apparently applied only to that meeting, as he is one of the co-authors of the revised opioid guideline — which has yet to be released publicly — and continues his involvement in federally funded pain research. 

OHSU researchers have conducted a series of reviews on a wide variety of pain therapies for the AHRQ. According to the website GovTribe, over the last five years OHSU has been awarded over $2 billion in federal grants for medical research. 

A group of patient advocates and researchers recently called for a congressional or DOJ investigation of the CDC opioid guideline, due to Chou’s significant role in writing it and his then-undeclared conflicts of interest.

Old Cancer Drug May Have New Purpose Treating Chronic Pain

By Pat Anson, PNN Editor

Over the years, several drugs that were developed to treat medical conditions such as epilepsy and depression have been repurposed as treatments for chronic pain — often with mixed results. Pregabalin (Lyrica) and duloxetine (Cymbalta) are just two examples.

A team of researchers at Duke University may have found a new pain medication while looking through what they call the “junkyard of cancer drugs.” They analyzed over 1,000 compounds contained in Compound Libraries at the National Cancer Institute, looking for drugs that reset genetic switches that control neurotransmission. Their goal was to find a drug that doesn’t just temporarily block pain signals, but changes the underlying mechanism that causes pain sensation.  

“Because chronic pain, like many chronic diseases, has an important root in genetic switches being reprogrammed in a bad way, a disease modifying treatment for chronic pain should reset the genetic switches, not just cover up the pain, as with opioid and aspirin/Tylenol-like painkillers." said Wolfgang Liedtke, MD, an adjunct professor of neurobiology at Duke and an executive scientist at Regeneron Pharmaceuticals.

Liedtke and his colleagues identified four promising compounds. Among them was kenpaullone, a drug developed over 20 years ago that inhibits neurotransmission by activating a gene called Kcc2. When Kcc2 is enhanced, it reduces chloride levels in nerve cells and silences pain signals.

In laboratory mice, Liedtke's team found that kenpaullone significantly reduced pain caused by nerve injury and bone cancer. The pain relief was long-lasting, which is consistent with the drug stopping pain signals through gene regulation.

"At this stage, we knew we had met the basic requirement of our screen of shelved cancer drugs, namely identified Kcc2 gene expression-enhancers, and demonstrated that they are analgesics in valid preclinical pain models,” Liedtke explained in a university press release.

Encouraged by their findings, Liedtke's team assessed whether kenpaullone affects spinal cord processing of pain and whether kenpaullone treatment can reduce chloride levels in pain-relaying neurons. Both sets of experiments on laboratory mice produced positive results.

The research findings, published in the journal Nature Communications, suggest that kenpaullone and gene therapy both have the potential to become treatments for chronic refractory pain conditions, such as neuropathy, cancer bone pain, trigeminal neuralgia, and other forms of chronic pain associated with poor Kcc2 function.

Controlling pain through experimental gene therapy is in its early stages, but has produced some intriguing results. In a study earlier this year, researchers at the University of California San Diego used a gene editing tool to alter a gene that senses pain in mice. The suppressed gene increased pain tolerance, lowered pain sensitivity and provided months of pain relief without the use of drugs.

More Americans Using Cannabis to Treat Chronic Pain Than Opioids

By Pat Anson, PNN Editor

Twice as many Americans are now using cannabis or cannabidiol (CBD) to manage their chronic pain than opioid medication, according to a new Harris Poll that found significant changes in pain management in the U.S. since the onset of the Covid-19 pandemic.

Over-the-counter pain relievers are used by over half (53%) of those surveyed, followed by cannabis products (16%) and non-opioid pain relievers (11%). Opioid pain medication is being used by only 8% of Americans with chronic pain. Non-drug treatments such exercise, heat/ice and healthy eating are also being widely used to relieve pain.

TREATMENTS USED TO MANAGE CHRONIC PAIN

SOURCE: SAMUELI FOUNDATION

The online survey of 2,063 adults was conducted last month on behalf of the Samueli Foundation. About half the participants said they were currently experiencing chronic pain.

One of the more surprising results is that young adults, aged 18 to 34, are more likely to have chronic pain than older ones (65% vs. 52% of those aged 35 and older).

“It is surprising, but we do know from other research that younger people are less healthy overall than older adults were at their age, so the higher prevalence of pain may be related to that. It seems that younger generations are facing health issues that were not experienced by older generations, causing them to be sicker and in more pain at a younger age,” said Wayne Jonas, MD, executive director of Integrative Health Programs at Samueli Foundation.

“There are a number of factors that could be at play here – and most of them can be attributed to lifestyle factors. Things like a poor diet, a lack of exercise, the growing pace of change and stress and very little self-care can lead to issues with a person’s health – physically, mentally, and emotionally. Chronic pain is a whole person issue with stress and social isolation contributing to its perpetuation. This is an issue that needs to be addressed in this population to ensure that as they age, their health doesn’t become precipitously worse.”

More than one in five young adults who have chronic pain (22%) said they use cannabis and/or CBD oil for pain, and they are twice as likely to do so compared to those aged 45 and older (11%).

“I think it’s clear that young people are looking for ways to manage their pain on their own – through self-care. And CBD and cannabis products are increasingly available and legal. People are feeling like they need to find their own ways to manage their pain because the care provided them may be lacking,” said Jonas, a clinical professor of Family Medicine at Georgetown University School of Medicine and former director of the National Institute of Health’s Office of Alternative Medicine.

The survey found that most adults with chronic pain don’t feel that healthcare providers are giving them adequate information on how to manage their pain. Nearly 80% wished their pain was taken more seriously by providers and 68% wished they had more information about how to treat chronic pain.

That lack of information – and no doubt the decreasing availability of opioids – has led to some experimentation. Two-thirds of Americans with chronic pain (66%) say they have changed their pain management since the pandemic began, such as using more OTC pain relievers and cannabis products. There is also more willingness to use non-drug treatments, such as exercise, healthier eating, massage, physical therapy, and mindfulness or meditation to reduce stress.

About 1 in 4 Americans say stress, anxiety and lack of sleep made their chronic pain worse during the pandemic. The vast majority of people in chronic pain (83%) say their quality of life would greatly improve if they were better able to manage it.

“This should be a wake-up call to physicians that their patients are looking for more information from them about managing their chronic pain, especially for non-drug approaches.” said Jonas.

How People With Pain Can Benefit From Pet Ownership

By Victoria Reed, PNN Columnist

Having chronic pain causes significant and daily challenges that can make life miserable, leading to depression and anxiety. As many people discovered during the pandemic, adopting a pet can be therapeutic, positively enhance your life, and may even reduce pain levels.

When my children were young, we adopted a senior dog from the local animal shelter. Bringing home Albert, a lab mix, turned out to be one of the best decisions we ever made for our family.

He instantly bonded with us, in particular with the youngest child. Albert became like an emotional support animal for her, as she suffers from severe anxiety and panic attacks. During times of stress, Albert was always there to calm her down. He just had a way of making her feel better and quickly became a valuable member of our family.  

We enjoyed seven great years with Albert before his health started to take a turn and, unfortunately, we had to say goodbye. Because we knew from the beginning that our time with him would be limited, we always appreciated Albert and tried to make the most of our time with him. He definitely gave us more than we ever could give him! 

Since my kids are mostly grown up now, I decided to adopt another pet and had hoped to re-create the bond that my daughter had previously with Albert.  

Lacey, a tiny poodle mix, has been everything I had hoped for. Not only is she a great little companion, but during bad days, when my rheumatoid arthritis or fibromyalgia are bothersome, she is always nearby, providing comfort, love and affection. She goes everywhere with me and has become an important part of my life.  

According to Dr. Steven Richeimer, a professor of anesthesiology at USC’s Keck School of Medicine, pets help relieve chronic pain by keeping us active and making us feel less stressed. 

“In my practice as a pain management specialist, I've heard numerous accounts of pets improving the lives of patients living with chronic pain and diminishing the depression that often accompanies it,” Richeimer wrote in Spine Universe. “There's no doubt in my mind that having a pet — or interacting with a trained therapy dog or cat — can improve a pain patient's quality of life. Animal companionship is a natural pain reliever, and a substantial body of research supports this theory.” 

One study of fibromyalgia patients found that just 10 to 15 minutes of petting a therapy dog lowered levels of cortisol, a stress hormone. Patients also reported significant improvement in their pain, mood and distress after a therapy dog visit.  

Chronic pain patient Jodi Tuckett found that fostering a dog named Suzy helped her recovery after she was seriously injured in a collision with a dump truck.  

“Having a little mangy mutt to look after shifted my focus away from me, my pain and my therapy team. She helps me when my neck, back and hips are hurting. I take her for a walk. Moving and keeping my joints loosened up makes me feel better. Suzy takes me out – out of the house, out of myself and out of my pain,” Tucket explained in Pain Pathways. 

Getting a pet, if you are financially and physically able to provide for one, can be beneficial to you physically and can improve your emotional state. There are many animals living in shelters and on the street that are in need of good homes!  

Rescued animals have so much love and affection to give, that you might wonder who’s doing the rescuing! I know that Albert and Lacey gave us many years of love, comfort and enjoyment, and I hope that other chronic pain patients will consider adding a pet to their lives. The benefits could surprise you! 

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis. 

Ketamine Gets FDA Orphan Drug Designation for CRPS

By Pat Anson, PNN Editor

A Canadian biotech company has announced it has been granted orphan drug designation from the U.S. Food and Drug Administration to investigate the use of ketamine as a treatment for Complex Regional Pain Syndrome (CRPS)¸ a disorder of the nervous system that causes severe, intractable nerve pain. Currently, there is no FDA approved medication for CRPS.

Toronto-based PharmaTher Holdings specializes in the development of ketamine and other psychedelic drugs for mental health and pain conditions. The company also recently received an orphan drug designation for ketamine as a treatment for Amyotrophic Lateral Sclerosis (ALS), more commonly known as Lou Gehrig's disease.

“Receiving our second FDA orphan drug designation with ketamine for CRPS continues our momentum in building a specialty ketamine-based product pipeline for not only mental health disorders, but also for rare and near-rare conditions present in neurological, pain and inflammatory disorders,” Fabio Chianelli, CEO of PharmaTher, said in a statement.

Ketamine is not an opioid, but acts on pain receptors in the brain in a similar manner. Although the drug is only approved by the FDA for anesthesia and depression, a growing number of clinics provide off-label infusions of ketamine to treat difficult chronic pain conditions such as CRPS. In high-dose infusions, ketamine puts patients into a temporary dream-like state that can lead to hallucinations and out-of-body experiences.

The FDA first approved ketamine in 1970 and the medical patent on it expired years ago. The goal of PharmaTher is to develop its own propriety formulation of ketamine and expand its use. Orphan drug designation helps speed that process along by encouraging companies to invest in new uses for old drugs, often jacking up the price in the process.

If successful, PharmaTher says it would have seven years of exclusive marketing rights for its ketamine formulation, as well as potential tax credits and the waiver of $2.4 million in FDA filing fees.

In 2019, the FDA approved Spravato, a ketamine-based nasal spray developed by Janssen Pharmaceuticals, as a treatment for depression. A single dose of Spravato costs about $900.

“It seems they are doing something similar to what Janssen did with Spravato,” says Kimberley Juroviesky, a retired nurse practitioner who receives ketamine infusions for CRPS. Juroviesky co-chairs an advocacy group that’s trying to get more insurance coverage of ketamine.

“They are taking ketamine and changing it slightly to create a new drug. Then they can charge hundreds for it. We are hopeful though that maybe this can help us in our fight to get generic ketamine covered by insurance,” she told PNN in an email.

PharmaTher plans to launch a Phase 2 clinical trial of its ketamine formulation in 2022. In addition to treating CRPS, the company recently began a clinical study of ketamine as a treatment for Parkinson’s disease, and has filed a patent application for ketamine as a treatment for obesity and Type 2 diabetes. PharmaTher is also developing a microneedle patch for the delivery of ketamine and other psychedelic drugs.

While ketamine is emerging as a trendy pain reliever and many patients swear by it, medical societies urge caution. Guidelines from the American Society of Anesthesiologists, American Society of Regional Anesthesia and Pain Medicine, and the American Academy of Pain Medicine only support ketamine infusions for CRPS and post-surgical acute pain. The guidelines say there is no evidence supporting ketamine infusions for any other type of pain.

A 2019 study of nearly 300 patients who received ketamine infusions found that over a third reported significant side effects such as hallucinations and visual disturbances.

Cities Sued to Make Sidewalks Accessible for Disabled People

By Maureen O’Hagan, Kaiser Health News

From her Baltimore dining room, Susan Goodlaxson can see her neighbor gardening across the street. But while other neighbors stop to chat, Goodlaxson just watches from the window. She uses a wheelchair, and there isn’t a single curb ramp on her block.

If the 66-year-old wanted to join, she’d have to jump her wheelchair down the 7½-inch curb and risk a fall. Ditto if she wanted to wheel over to the library, a trip that would require riding in the street to avoid rampless curbs and broken sidewalks.

“I don’t feel like it’s asking too much to be able to move your wheelchair around the city,” she said.

Federal law backs her up. Since 1990, the Americans With Disabilities Act has required governmental entities to provide people with disabilities access to programs and services enjoyed by their nondisabled peers. That includes sidewalks and curb ramps that make it possible to safely cross the street.

In Baltimore and many other communities across the U.S., there has been widespread noncompliance with this part of the law.

“An awful lot of [communities] have either disregarded their obligations under the ADA or made it the last priority,” noted Tom Stenson, a lawyer with Disability Rights Oregon, a nonprofit advocacy group. “There’s a culture throughout America of not taking the needs of people with disabilities seriously.”

SUSAN GOODLAXSON

In Baltimore, just 1.3% of curb ramps meet federal standards, according to the city’s own figures. In Oregon, about 9% of corners maintained by the state transportation department are compliant. San Jose, California, counted 27,621 corners with faulty or nonexistent curb ramps. Boston estimates fewer than half of its curb ramps are compliant.

Class-Action Lawsuits

In recent years, there’s been a flurry of class-action lawsuits, including one filed against Baltimore in June, with Goodlaxson among the plaintiffs.

Philadelphia was sued in 2019 over the condition of its sidewalks. Chicago was sued the same year for failure to install audible pedestrian signals, more than a decade after settling a suit over curb ramps.

In 2018, Atlanta was sued. A survey there determined that only 20% of sidewalks were in sufficient condition to be used by people in wheelchairs or motorized scooters and about 30% had curb ramps. Seattle settled a class-action suit in 2017. San Francisco and Long Beach, California, were sued in 2014 to make their sidewalks more accessible to wheelchairs.

The city of New York and its transit authority have faced repeated major ADA lawsuits, some alleging the same lack of access for people with disabilities that was supposed to be addressed in a lawsuit that was filed in the 1990s and later settled.

Los Angeles settled what is believed to be the largest of these suits in 2015. Its problems with sidewalks and curb ramps were so widespread that the city estimated it would cost $1.4 billion and take 30 years to get into compliance. In the years leading up to the suit, the city wasn’t allocating money for sidewalk repairs, for the ADA or otherwise, even while paying out millions in injury claims.

In all, hundreds of jurisdictions have faced lawsuits or entered settlement agreements after failing to meet ADA requirements for pedestrians and mass transit users.

The sheer number of noncompliant sidewalks, curb ramps, pedestrian signals and subway stations illustrates the challenges for people with disabilities.

It also leaves cities in a legal and financial squeeze, with the average curb ramp costing between $9,000 and$19,000. When the court requires a jurisdiction to build thousands of them to catch up, it can strain budgets.

Rosem Morton / for KHN

The ADA and the 1973 Rehabilitation Act resulted in significant changes that improved access and accommodations for people with disabilities. The ADA is clear that people with disabilities have the same right to pedestrian infrastructure as anyone else.

There are requirements covering a curb ramp’s width, slope and other specifications. Even a 1-inch lip can be too high for a wheelchair user to navigate. A slope that is a few degrees too steep can tip someone to the ground. Sidewalks that are crumbling, pothole-filled or otherwise obstructed — with utility poles, for example — force wheelchair users into the street for a dangerous ride.

No one expected the ADA to fix all these problems immediately. Under the law, new sidewalks must be built for accessibility. As for existing sidewalks, a federal appeals court in 1993 ruled that curb ramps must be installed or regraded when the road is altered — say, when it’s repaved.

Compliance Lags

Yet by 1999 it was clear many jurisdictions were ignoring the law. The U.S. Department of Justice began enforcement efforts, entering into settlement agreements with more than 200 non-compliant jurisdictions representing every state since 2000.

Still, compliance still lags.

Officials in Baltimore, New York and Los Angeles declined to comment for this article. Tony Snyder, manager of the Oregon Department of Transportation’s ADA program, said siloed funding sources, strict regulations and costs have been among the hurdles over the years.

“It wasn’t that ODOT doesn’t value accessibility,” he said. While fewer than 10% of the state’s ramps meet standards, he said, a lot of noncompliant ramps are nonetheless “usable.”

Kelly Lynch, deputy director and general counsel for the Montana League of Cities and Towns, an association that represents 127 municipal governments, agreed that costs can add up. She’s been working to help fellow Montanans —and, she hopes, officials in other jurisdictions across the country through the National League of Cities — find a path toward full accessibility, even if the steps are incremental.

Some changes, including educating road crews on the rules, are relatively simple. But a bigger problem is a widespread lack of spending on the nation’s infrastructure. “Our streets are falling apart, and so are our sidewalks,” Lynch said.

In August, the Senate defeated an amendment by Sen. Tammy Duckworth (D-Ill.) to a $1 trillion infrastructure bill that would have required state and local entities to describe how they would use federal dollars to improve accessibility for people with disabilities and for underserved communities. Sen. Pat Toomey (R-Pa.) called Duckworth’s amendment “politically correct virtue signaling” and argued that transit agencies don’t need that kind of federal oversight.

On top of the broader infrastructure issues, many officials don’t fully understand the ADA or its requirements, Lynch believes. And as the mother of a disabled son, she also said there’s another big factor at play: “People still discriminate against people with disabilities.”

As for Baltimore, Goodlaxson said she repeatedly called the city asking for curb cuts and sidewalk repairs. She remembers a crew coming to look at the sidewalks — and then nothing happening.

Advocacy organizations tried to negotiate with city officials, hoping to get Baltimore’s infrastructure brought into compliance on a timetable. When that didn’t work, they filed suit.

Most of these kinds of ADA cases begin similarly, with negotiations long before lawsuits. Some jurisdictions settled quickly and worked hard at improvements. Other cases go less smoothly. Oregon’s transportation department, which was also sued, is in danger of missing its construction deadlines under the settlement. Some repairs had to be redone because they still fell short of ADA requirements.

Sometimes cities try to get cases thrown out of court by pointing to the 1993 appeals court decision and arguing there’s no evidence the road has been altered since then, so ADA requirements haven’t kicked in. In New York, the transit authority argues in an ongoing lawsuit that while wheelchair users can’t ride, say, three-quarters of the city’s subways because there are no elevators, they can instead take the bus.

Some jurisdictions fight bitterly. Los Angeles spent five years in court before agreeing to settle. Linda Dardarian, one of the plaintiff’s attorneys, said cities don’t fully recognize sidewalk and curb ramp accessibility as a civil right. “They have viewed it as just another maintenance obligation, [like] grooming street trees.”

When the case was settled, the judge ordered Los Angeles to pay nearly $12 million to cover the other side’s legal fees and costs, on top of the estimated $1.4 billion it will cost to come into compliance.

Under these settlements, repairs often stretch a decade or more, and the city or town typically must pay for surveys, measurements and disability consultants to ensure compliance.

From the plaintiffs’ point of view, the challenge of these lawsuits is that there isn’t a huge hammer to hold governments accountable.

“If you don’t build the ramps, the penalty is you have to build the ramps,” said Stenson of Disability Rights Oregon, which provided legal representation to a plaintiff in the Oregon transportation department suit.

For those who can easily get around town, the issue can be invisible.

Goodlaxson didn’t see the problem until she began using a wheelchair five years ago, after surgery for a brain tumor. She remembers seeing people riding their wheelchairs in the street, thinking, “that doesn’t look safe. But I didn’t give it any more thought.”

Now, she realizes “people are terrified, but they can’t do it any other way.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

General Anesthesia as Safe as Spinal Injections for Hip Fracture Surgery

By Pat Anson, PNN Editor

General anesthesia is just as safe as spinal anesthesia for patients undergoing hip fracture surgery, according to a large new study that dispels a common belief that patients who receive spinal injections have better outcomes.

Researchers from the Perelman School of Medicine at the University of Pennsylvania enrolled 1,600 mostly elderly patients having hip fracture surgery at 46 U.S. and Canadian hospitals, and randomly assigned them to receive either spinal or general anesthesia.

They found that rates of survival, delirium and functional recovery post-surgery were similar for patients, regardless of the type of anesthesia they received. The findings are published in The New England Journal of Medicine.

“Our study argues that, in many cases, either form of anesthesia appears to be safe," said lead investigator Mark D. Neuman, MD, an associate professor of Anesthesiology and Critical Care at Perelman. "This is important because it suggests that choices can be guided by patient preference rather than anticipated differences in outcomes in many cases."

During general anesthesia, inhaled and intravenous medications are used to make patients unconscious, which often requires a breathing tube during surgery. For spinal anesthesia, medications are used to numb the lower part of the body through an injection into the spinal column. Patients anesthetized this way are typically able to breathe on their own during surgery and rarely require a breathing tube.

About 250,000 people have hip fracture surgery annually in the United States. In the past, most would receive general anesthesia, but in recent years the use of spinal anesthesia for hip fracture surgeries has increased significantly, due in part to the belief by some anesthesiologists that it was safer for frail, older patients.  

To get a better idea of possible outcomes associated with both forms form of anesthesia, researchers looked at post-surgical death rates, whether patients regained the ability to walk, and if they experienced any cognitive decline.

Statistically, there was hardly any difference in outcomes between the two groups. Sixty days after surgery, 18.5% of patients assigned to spinal anesthesia had either died or were unable to walk; versus 18 percent of patients who received general anesthesia. About 21 percent of patients assigned to spinal anesthesia experienced delirium, versus 20 percent of those given general anesthesia.

"What our study offers is reassurance that general anesthesia can represent a safe option for hip fracture surgery for many patients," said Neuman. "This is information that patients, families, and clinicians can use together to make the right choice for each patient's personalized care."

Neuman and his research team say previous comparisons of general and spinal anesthesia came from studies that didn’t randomly assign patients, which creates self-selection bias. Some patients may have chosen spinal anesthesia with the goal of avoiding complications, while others opted for general anesthesia to avoid a spinal injection or because they feared inadequate sedation during surgery.

The most common types of medications used during spinal injections are anesthetics, opioids or corticosteroids. A recent study of patients with hip osteoarthritis warned of serious long-term complications for those given steroid injections. Patients who received steroids were 8.5 times more likely to develop rapidly destructive hip disease, a condition that causes the loss of blood flow and death of bone tissue in the hip.